STRIDE - STimulating Immune Response In aDvanced brEast Cancer (NCT00925548) | Clinical Trial Compass
TerminatedPhase 3
STRIDE - STimulating Immune Response In aDvanced brEast Cancer
Stopped: See termination reason in the below Purpose statement
United States, Australia, Austria16 participantsStarted 2009-09
Plain-language summary
EMD Serono has decided to permanently terminate the trial EMR 200038-010 (STRIDE) in the indication of breast cancer following the clinical hold on the investigational new drug application for tecemotide (L-BLP25).
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Postmenopausal women as defined in the protocol
* Estrogen receptor (ER)-positive and/or progesterone receptor (PgR)-positive, histologically or cytologically confirmed primary carcinoma of the breast
* Expressing at least one of the following five human leukocyte antigen (HLA) haplotypes, as centrally assessed by HLA genotyping from whole blood: HLA-A2, -A3, -A11, -B7, or -B35
* Locally advanced, recurrent, or metastatic breast cancer (Subject must have at least one lesion not located in bone)
* Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST), and inoperable
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate hematologic, hepatic, and renal function within two weeks prior to initiation of therapy, as defined by the protocol
* Other protocol-defined inclusion criteria may apply
Exclusion Criteria:
Disease Status
* PD either during hormonal therapy for early breast cancer (adjuvant therapy) or within 48 months from the initiation of such therapy
* Human epidermal growth factor receptor 2-positive (HER2+) breast cancer as defined in the protocol
* Autoimmune disease that in the opinion of the investigator could compromise the safety of the subject in this study (Exception will be granted for well-controlled Type I diabetes mellitus)
* Recognized immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; hereditary or congenital immunodeficie…
What they're measuring
1
Progression-Free Survival (PFS)
Timeframe: Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010